A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00311519
• Date of registration: 04/04/2006
• Primary sponsor: Halozyme Therapeutics
• Public title: A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects
• Scientific title: A Phase IIIB Double Blind, Randomized, Placebo-Controlled, Dose-Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects
• Date of first enrolment: November 2005
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00311519
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Javier T Quesada, OD
• Affiliation: West Coast Clinical Trials

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males or females aged 18 to 60 years, inclusive

2. Agreement that there will be no fluid intake for 12 hours prior to the start of the
study infusion (except sips of water to take necessary medications)

3. Vital signs (BP, HR, RR) within normal range

4. Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine,
glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total
protein) within normal range within 7 days of infusion

5. Adequate venous access in at least one forearm

6. A negative pregnancy test (if female of child-bearing potential) within 7 days of
infusion

7. Decision-making capacity

8. Signed, written IRB-approved informed consent

Exclusion Criteria:

1. Extremity edema

2. Upper extremity pathology that could interfere with study outcome (e.g., cellulitis,
lymphatic disorder or prior surgery, pre-existing pain syndrome, previous mastectomy
and/or axillary lymph node dissection, etc.)

3. History of cardiovascular disease

4. Rales on lung auscultation

5. Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX

6. Known allergy to bee or vespid venom

7. Known coagulopathy



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Hylenex

Primary Outcome(s)

Average infusion flow rate (mL/hr) derived from the time to infuse 400 mL of lactated ringers

Secondary Outcome(s)

Average SC infusion rate of flow (mL/hr) derived from time required to drain 400 mL from the 500 mL infusate bag, fluid and tubing AND for the arm circumference to return to baseline

Flow rate determined by weight of infusate bag, fluid and tubing at specified timepoints

For SC infusions, change in arm circumference in three locations in the vicinity of the site of infusion

For SC infusions, time from the beginning of infusion until arm circumference returns to baseline

Investigator’s global rank-ordered preference for infusion

Leakage of fluid at angiocatheter site assessed by the Investigator on a 0-4 scale, prior to infusion, at mid-infusion, at end of infusion, and (for SC infusions), when arm circumference returns to baseline

Local edema assessed by the Investigator on a 0-4 scale

Photographic images of the SC infusion sites

Safety and tolerability, based on adverse events and PE including vital signs

Subject assessment of local discomfort by placing a mark on a 0 100 mm visual analogue scale (VAS) anchored by no discomfort and worst possible discomfort

Subject’s global rank-ordered preference for infusion

Secondary ID(s)

HZ2-05-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors